Under-resourced FDA unable to regulate food safety, says former official

The Food and Drug Administration (FDA) is under-resourced,
under-staffed, and essentially incapable of overseeing potential
threats to the US food supply, according to a former FDA official
who last week opposed the National Uniformity for Food Act at a
Senate hearing.

Recently retired William Hubbard, who spent 33 years in federal
service, said he has been repeatedly involved in the issue of
national uniformity for food safety laws over the years.

And according to him, implementing the National Uniformity for
Food Act at the present time would replace a federal/state
partnership that effectively monitors the nation's food safety with
an impractical, ineffective system that would create a "vacuum
in safety oversight".​

Hubbard was speaking at a hearing of the Senate Committee on
Health, Education, Labor and Pensions (HELP) last Thursday. The
event was designed to examine the support and opposition for the
proposed bill, which could standardize warning labels and food
safety requirements throughout the US.

The bill, also known as S. 3128, was approved in the House of
Representatives in March and is now due to be considered by the
Senate.

But Hubbard painted a picture of an FDA regulatory structure
that is incapable of meeting the nation's growing demands to
oversee food production, food additives, dietary supplements,
nutrition labeling, foods produced from biotechnology, foodborne
disease outbreaks and dangerous new pathogens that infect food.

He stated that in 1972, around half of FDA's resources were
allocated to its food program. Today, that figure has fallen to
about one-quarter, even though the agency has little more staff
than it had in the 1970's.

He also pointed out that 34 years ago FDA conducted 35,000
inspections of food manufacturing facilities. This year, he said,
it will conduct around 5,000.

Another example he used was the volume of food imports from
overseas, which is approaching 10 million per year. But the number
that FDA inspectors physically examine is in the single digit
thousands, according to Hubbard, making it virtually certain that
any given food shipment will enter the US with no FDA
inspection.

In contrast, the current system of state and federal
collaborations has worked relatively well, he told the
committee.

"There certainly has not been the sort of mass conflict and
confusion that would warrant a fundamental undermining of the
strong federal/state partnership that currently exists. And the
states have served the valuable function at times of being the
first to identify a health risk and, through their actions to
protect their own citizens, have alerted the FDA, so that it could
extend such protections nationally,"​ he said.

"Yet S. 3128, in the name of 'uniformity,' would remove FDA's
partner in protecting against food adulteration, and throw even
more responsibilities at the agency-in effect, moving problem
solving from a source that has proven to be an effective complement
to Federal authorities to one that cannot accept more
responsibility and will thus be ineffective,"​ he added.

Hubbard also claimed that the provision in the bill that allows
for states to petition the FDA to adopt an existing state standard
as the national standard is "simply impractical".​

According to the Congressional Budget Office, the FDA would
receive at least 200 state petitions during the first year after
the bill's enactment, and it would cost $400,000 to review each
petition, he said. This would mean that the FDA would be required
to spend$80 million to answer those petitions- "for no
discernible public health gain."​

"Mr. Chairman, the entire budget for salaries and expenses of
the scientists in FDA's headquarters food program is under $100
million, so this bill, if enacted, wouldessentially mean that the
food program would need to cease all other functions except forthe
review of state petitions, if it were to make a sincere effort to
comply with Congress'scharge,"​ Hubbard said.

He added that the FDA has "shown demonstrably that resource
constraints prevent it from processing the flow of citizen
petitions that it currently​ receives."

Hubbard concluded his address by stressing the FDA's
"absolute inability to implement this bill in any reasonable
fashion."​

"When a well resourced FDA has been able to examine a
potential health risk in food, bringing to bear the best scientific
data and analytical ability, and resulting in the establishment of
a reasoned determination (…) it would be reasonable to consider
whether that determination should be dispositive for the entire
nation, and whether states should second guess such a carefully
reasoned disposition."​

"However, until and unless FDA is given the resources and
ability to deal with any and all questions about the safety of food
constituents, I believe that the existing federal/state cooperative
relationship has passed the test of time in its effectiveness and
ability to work together to protect our citizenry."​

Other speakers at the hearing included William Stadtlander, the
owner of Homestat Farm, which manufactures the 'healthy' cereal
product Wheatena, and who was sued under California law because his
product contains acrylamide.

Peter Hutt, senior counsel at Covington and Burling law firm
also addressed the Committee, expressing his support for the bill
and outlining its main features.

For the FoodNavigator-USA.com article on the hearing, click
here.​
For coverage of the address by Stadtlander, click here.​
For coverage of the address by Hutt, click here​.